SensiLase Studycast System: A Platform for Critical Limb Diagnostics and Electronic Referral Program.

PROBLEM: Peripheral arterial disease (PAD) and critical limb ischemia (CLI) impede lower extremity wound healing. The highest-risk patient populations have foot ulcers, ischemic disease, diabetes mellitus, and/or compromised kidney function. Optimal wound healing protocols require evaluation of both tissue and arterial perfusion. The most widely known test, ankle brachial index (ABI), has general but limited utility in foot ulcer patients. False negatives secondary to medial artery calcification are common and ABI alone is not considered predictive of wound healing. As many high-risk patients consider their medical home to be their primary care physician (PCP) not a limb preservation center (LPC), high-risk patients can be underserved secondary to inadequate awareness of the disease, limited diagnostics, and inefficient referral. SOLUTION: Access to clinically appropriate, tissue-diagnostic tools for high-risk populations coupled with health information transfer (HIT) between PCP and LPCs provides the opportunity to bring PAD/CLI expertise to a patient's medical home. Coordinated data management coupled with PAD/CLI protocols can promote timely and appropriate referral and subsequent intervention. NEW TECHNOLOGY: SensiLase® Studycast® System provides a noninvasive diagnostic and data management system specifically designed for high-risk patients. Studycast software automates and simplifies HIT between the PC and critical limb care experts at the LPC. Data can be integrated with existing electronic medical record systems. INDICATIONS FOR USE: SensiLase Studycast is indicated for perfusion assessment in patients at high risk for peripheral ischemia. CAUTION: Results of SensiLase System testing should be used in conjunction with other diagnostic information in formulating therapeutic plans.